Very loyal readers may recall that Lemin Wu was a Berkeley Ph.D in economic history and a student of Brad DeLong. Then he seemed to disappear. But for the last few years he was been working and writing, and later in 2020 he has a book coming out in China, in Chinese, title still undetermined.
I have read only parts of the book (the parts in English), and an outline. Still , I am willing to predict it will be the best and most important economics book of the year, in any language. It also likely will mark the first time a Chinese economist, writing in Chinese, created an important work.
I won’t “give away the plot,” but suffice to say it is about the rise of the West, the Malthusian model, group selection in history, why development takes so long, and related big topics. Oh, and it does tie in to and draw upon Cixin Liu’s The Three-Body Problem, just in case you were wondering.
I hope very much this book will be published in English as well.
Hail Lemin Wu!
I had an excellent time in this one, here is the audio and transcript. Here is the opening summary:
Abhijit joined Tyler to discuss his unique approach to economics, including thoughts on premature deindustrialization, the intrinsic weakness of any charter city, where the best classical Indian music is being made today, why he prefers making Indian sweets to French sweets, the influence of English intellectual life in India, the history behind Bengali leftism, the best Indian regional cuisine, why experimental economics is underrated, the reforms he’d make to traditional graduate economics training, how his mother’s passion inspires his research, how many consumer loyalty programs he’s joined, and more.
Yes there was plenty of economics, but I feel like excerpting this bit:
COWEN: Why does Kolkata have the best sweet shops in India?
BANERJEE: It’s a bit circular because, of course, I tend to believe Kolkata has —
COWEN: So do I, however, and I have no loyalty per se.
BANERJEE: I think largely because Kolkata actually also — which is less known — has absolutely amazing food. In general, the food is amazing. Relative to the rest of India, Kolkata had a very large middle class with a fair amount of surplus and who were willing to spend money on. I think there were caste and other reasons why restaurants didn’t flourish. It’s not an accident that a lot of Indian restaurants were born out of truck stops. These are called dhabas.
BANERJEE: Caste has a lot to do with it. But sweets are just too difficult to make at home, even though lots of people used to make some of them. And I think there was some line that was just permitted that you can have sweets made out of — in these specific places, made by these castes.
There’s all kinds of conversations about this in the early-to-mid 19th century on what you can eat out, what is eating out, what can you buy in a shop, et cetera. I think in the late 19th century you see that, basically, sweet shops actually provide not just sweets, but for travelers, you can actually eat a lunch there for 50 cents, even now, an excellent lunch. They’re some savories and a sweet — maybe for 40 rupees, you get all of that.
And it was actually the core mechanism for reconciling Brahminical cultures of different kinds with a certain amount of social mobility. People came from outside. They were working in Kolkata. Kolkata was a big city in India. All the immigrants came. What would they eat? I think a lot of these sweet shops were a place where you actually don’t just get sweets — you get savories as well. And savories are excellent.
In Kolkata, if you go out for the day, the safest place to eat is in a sweet shop. It’s always freshly made savories available. You eat the freshly made savories, and you get some sweets at the end.
COWEN: Are higher wage rates bad for the highest-quality sweets? Because rich countries don’t seem to have them.
BANERJEE: Oh no, rich countries have fabulous sweets. I mean, at France —
COWEN: Not like in Kolkata.
BANERJEE: France has fabulous sweets. I think the US is exceptional in the quality of the . . . let me say, the fact that you don’t get actually excellent sweets in most places —
And this on music:
BANERJEE: Well, I think Bengal was never the place for vocal. As a real, I would say a real addict of vocal Indian classical music, I would say Bengal is not, never the center of . . . If you look at the list of the top performers in vocal Indian classical music, no one really is a Bengali.
In instrumental, Bengal was always very strong. Right now, one of the best vocalists in India is a man who lives in Kolkata. His name is Rashid Khan. He’s absolutely fabulous in my view, maybe the best. On a good day, he’s the best that there is. He’s not a Bengali. He’s from Bihar, I think, and he comes and settles in Kolkata. I think a Hindi speaker by birth, other than a Bengali. So I don’t think Bengal ever had top vocalists.
It had top instrumentalists, and Ravi Shankar, Ali Akbar Khan, Nikhil Banerjee — these were all Bengali instrumentalists. Even now, I would say the best instrumentalists, a lot of them are either Bengali or a few of them are second . . . Vilayat Khan and Imrat Khan were the two great non-Bengali instrumentalists of that period, I would say, of the strings especially. And they both settled in Kolkata, so that their children grew up in Kolkata.
And the other great instrumentalists are these Kolkata-born. They went to the same high school as I did. There were these Kolkata-born, not of Bengali families, but from very much the same culture. So I think Kolkata still is the place which produces the best instrumentalists — sitarists, sarod players, et cetera.
COWEN: Why is the better vocal music so often from the South?
Definitely recommended, Abhijit was scintillating throughout.
I find windmills beautiful but many people disagree, even in environmentally conscious Germany.
Bloomberg:…it’s getting harder to get permission to erect the turbine towers. Local regulations are getting stricter. Bavaria decided back in 2014 that the distance between a wind turbine and the nearest housing must be 10 times the height of the mast, which, given the density of dwellings, makes it hard to find a spot anywhere. Wind energy development is practically stalled in the state now. Brandenburg, the state surrounding Berlin, passed a law this year demanding that wind-farm operators pay 10,000 euros ($11,100) per turbine each year to communities within 3 kilometers of the windmills.
…local opponents of the wind farms often go to court to stall new developments or even have existing towers dismantled. According to the wind-industry lobby BWE, 325 turbine installations with a total capacity of more than 1 gigawatt (some 2% of the country’s total installed capacity) are tied up in litigation. The irony is that the litigants are often just as “green” as the wind-energy proponents — one is the large conservation organization NABU, which says it’s not against wind energy as such but merely demands that installations are planned with preserving nature in mind. Almost half of the complaints are meant to protect various bird and bat species; others claim the turbines make too much noise or emit too much low-frequency infrasound. Regardless of the validity of such claims, projects get tied up in the courts even after jumping through the many hoops necessary to get a permit.
Another reason for local resistance to the wind farms is a form of Nimbyism: People hate the way the wind towers change landscapes. There’s even a German word for it, Verspargelung, roughly translated aspollution with giant asparagus sticks.
As I wrote earlier, more and more the sphere of individual action shrinks and that of collective action grows and, as a result, nothing can get done because there are so many veto players in the system. We have locked ourselves into an innovation prisoner’s dilemma where each player can say no and as a result we are all worse off.
The Lancet Commission on Pollution and Health, an authoritative review with well-over a dozen distinguished co-authors, is unusually forthright on the effect of pollution, most especially lead, on IQ. I think some of their numbers, especially in paragraph three, are too large but the direction is certainly correct.
Neurotoxic pollutants can reduce productivity by impairing children’s cognitive development. It is well documented that exposures to lead and other metals (eg, mercury and arsenic) reduce cognitive function, as measured by loss of IQ.168
Loss of cognitive function directly affects success at school and labour force participation and indirectly affects lifetime earnings. In the USA, millions of children were exposed to excessive concentrations of lead as the result of the widespread use of leaded gasoline from the 1920s until about 1980. At peak use in the 1970s, annual consumption of tetraethyl lead in gasoline was nearly 100 000 tonnes.
It has been estimated that the resulting epidemic of subclinical lead poisoning could have reduced the number of children with truly superior intelligence (IQ scores higher than 130 points) by more than 50% and, concurrently, caused a more than 50% increase in the number of children with IQ scores less than 70 (figure 14).265 Children with reduced cognitive function due to lead did poorly in school, required special education and other remedial programmes, and could not contribute fully to society when they became adults.
Grosse and colleagues 46 found that each IQ point lost to neurotoxic pollution results in a decrease in mean lifetime earnings of 1·76%. Salkever and colleagues 266 who extended this analysis to include the effects of IQ on schooling, found that a decrease in IQ of one percentage point lowers mean lifetime earnings by 2·38%. Studies from the 2000s using data from the USA 267,268 support earlier findings but suggest a detrimental effect on earnings of 1·1% per IQ point.269 The link between lead exposure and reduced IQ 46, 168 suggests that, in the USA, a 1 μg/dL increase in blood lead concentration decreases mean lifetime earnings by about 0·5%. A 2015 study in Chile 270 that followed up children who were exposed to lead at contaminated sites suggests much greater effects. A 2016 analysis by Muennig 271 argues that the economic losses that result from early-life exposure to lead include not only the costs resulting from cognitive impairment but also costs that result from the subsequent increased use of the social welfare services by these lead-exposed children, and their increased likelihood of incarceration.
This book is more than 1000 pp., here are my impressions:
1. About 600 pp. of this book is a carefully done history of the accumulation and sometimes dissipation of wealth and property. You can evaluate that material without reference to any particular set of political views.
2. At some point the book veers into partisan issues such as the wealth tax. Many of those parts remain interesting, but it also becomes clear that Piketty is “out to lunch,” to wit (p.591):
To return to the Soviet attitude toward poverty, it is important to try to understand why the government took such a radical stance against all forms of private ownership of the means of production, no matter how small. Criminalizing carters and food peddlers to the point of incarcerating them may seem absurd, but there was a certain logic to the policy. Most important was the fear of not knowing where to stop. If one began by authorizing private ownership of small businesses, would one be able to set limits?
I can think of a less naive explanation of Soviet attitudes toward the private sector. Piketty also calls for “participatory socialism” (p.592), a dubious doctrine not to be confused with say Nordic social democracy. For instance, Sweden (among other countries) seems to have fairly extreme wealth inequality.
3. The sentence “Real wages are much higher in America than in Western Europe” does not come easily to his pen. Nor does “The United States is a remarkably successful innovator, let’s see what we can learn from that.” Or even “Raising wages is more important than merely limiting inequality.” Those seems to be banished thoughts in the Piketty intellectual universe.
4. The sections on Soviet and socialist experience can only be called “delusional.” In his account, if only a few political decisions had gone the other way, the USSR might have ended up on a path similar to that of Norway (p.603 and thereabouts).
You know, maybe you think that the inequalities of the current day are much worse than people had been expecting. but that should not revise your view of socialism and the Soviet Union, two matters fairly well settled by historical research.
5. Give these lenses, it is impossible for Piketty to offer any commentary on recent events (about the last 400 pp. of the book) that is anything other than distorted and unreliable. There is massive distrust of the wealthy in this book, and virtually no distrust of concentrated state power.
6. There is a considerable sum of useful and valuable material in this book, and I would not try to dissuade anyone inclined from reading it. Nonetheless I suspect its main import is as another sign of the growing compartmentalization of academic discourse — good work intermingled with highly questionable partisan material — and how so many academics, if the mood affiliation tilts in the right direction, will tolerate or even encourage that.
You can pre-order the book here.
Japan now has over 70,000 people who are more than 100 years old.
That stunning fact comes from Extreme Economies, an interesting new book by Richard Davies. Davies looks at extreme economies around the world such as extreme failure (Darien, Kinshasa, Glasgow), extreme resilience (Aceh, Angola Prison, LA), extreme inequality (Santiago) and in the case of Japan (Akita), extreme aging.
Japan’s aging is unprecedented and is having effects throughout the economy and society:
In 1975 social security and healthcare spending commanded 22 percent of the country’s tax revenues; by 2017 the figure, driven up by elderly care and pensions, had risen to 55 percent. By the early 2020s the figure is set to hit 60 percent. To look at it in another way, every other public service in Japan — education, transport, infrastructure, defense, the environment, the arts–could rely on almost 80 percent of tax revenue in 1975, but the increase in elderly-related spending means that only 40 percent is left for other national public expenditures. In budgetary terms, ageing is eating Japan.
As a country, Japan is aging not just because it’s people are getting older but because it’s birth rate is well below replacement. This year there will be fewer than 900,000 births in all of Japan–a number not seen since 1874 when Japan’s total population was much smaller. Overall, Japan’s population is declining.
Population decline may have some good effects but the combination of fewer young people and more elderly people is straining Japanese culture along with its finances. The young naturally resent the increasing burden put on them for supporting the elderly. As with all Ponzi schemes, pay-as-you-go social security schemes come under stress when the population is no longer growing.
…over the next 30 years or so, many countries’ pension systems will require young workers to fund a system that everyone knows will be far less generous by 2040. It is hardly a way to generate confidence in public policy.
And those 70,000 centenarians? Almost 90 percent are women so an aging society is a gender unbalanced society meaning old people lose caregivers or at least someone to share a household with.
Davies is interested in Japan as an example of where many countries are going,
Southern Europe, in particular, is following fast with Italy, Spain and Portugal already experiencing population decline. Germany will start to shrink in 2022, Korea in the early 2030s. Akita, Japan’s cutting edge of ageing economics,…offers a valuable window on the future.
Nearly 400 people who were either wounded while serving in the U.S. military in Afghanistan or are family members of service members who died in the conflict sued a group of companies on Friday they say helped fund attacks against Americans by making protection payments to the Taliban.
“Defendants supported the Taliban for a simple reason: Defendants were all large Western companies with lucrative businesses in post-9/11 Afghanistan, and they all paid the Taliban to refrain from attacking their business interests,” the 288-page complaint filed in federal court in Washington, D.C. on Friday states. “Those protection payments aided and abetted terrorism by directly funding an al-Qaeda-backed Taliban insurgency that killed and injured thousands of Americans.”
Relying on confidential witnesses, internal documents and publicly available information from journalists, government watchdogs and congressional hearings, the complaint alleges companies that worked in war-torn Afghanistan commonly acceded to the Taliban’s mob-style demands for payment in exchange for the guarantee that their businesses interests would not be attacked.
One unnamed American executive who worked in Afghanistan is quoted in the complaint as saying “We don’t need any security if the payments are made. Nobody f—s with us.”
The payments allegedly climbed as high as 40% of the value of the company’s project and were often facilitated through subcontractors. The subcontractors, such as private security firms that were known to pay off the Taliban, would sometimes send money through Afghanistan’s traditional money transfer network, which can be hard to trace. Other times, the companies would simply hire Taliban operatives to work as guards.
Here is the full story.
Check out the new NBER paper by Joseph Grourko, Jonathan Hartley, and Jacob Krimmel:
We report results from a new survey of local residential land use regulatory regimes for over 2,450 primarily suburban communities across the U.S. The most highly regulated markets are on the two coasts, with the San Francisco and New York City metropolitan areas being the most highly regulated according to our metric. Comparing our new data to that from a previous survey finds that the housing bust associated with the Great Recession did not lead any major market that previously was highly regulated to reverse course and deregulate to any significant extent. Moreover, regulation in most large coastal markets increased over time.
One embedded lesson is that the number of veto points over new construction is increasing. And “By our metric, about one half of all communities in the Regulation Change index increased regulation, one-third decreased, while only 18 percent showed no net change.”
Here is a graph of housing affordability vs. their index of restrictiveness:
Here is my earlier Bloomberg column calling for more indices — this is exactly what I wanted.
Here are the top MR posts for 2019, as measured by landing pages. The most popular post was Tyler’s
Alas, I don’t think that will help to create more Tylers. Coming in at number two was my post:
Other posts in the top five were 3. Pretty stunning data on dating from Tyler and my posts, 4. One of the Greatest Environmental Crimes of the 20th Century,and 5. The NYTimes is Woke.
My post on The Baumol Effect which introduced my new book Why are the Prices So Damned High (one of Mercatus’s most downloaded items ever) was number 6 and rounding out the top ten were a bunch from Tyler, including 7. Has anyone said this yet?, 8. What is wrong with social justice warriors?, 9. Reading and rabbit holes and my post Is Elon Musk Prepping for State Failure?.
Other big hits from me included
- Air Pollution Reduces IQ, a Lot (Mostly a Patrick Collison post)
- The Nobel Prize in Economic Science Goes to Banerjee, Duflo, and Kremer
- Bitcoin is Less Secure than Most People Think
- Active Learning Works But Students Don’t Like It
- Sex Differences in Personality are Large and Important
Tyler had some truly great posts in the last few days of 2019 including what I thought was the post of the year (and not just on MR!) Work on these things.
Also important were:
- “What will you do to stay weird?”
- Amazon and Taxes a Simple Primer
- Best Non-fiction books of 2019.
Happy holidays everyone!
Now this one is a stunner:
The college income premium—the extra income earned by a family headed by a college gra duate over an otherwise similar family without a bachelor’s degree—remains positive but has declined for recent graduates. The college wealth premium (extra wealth) has declined more noticeably among all cohorts born after 1940. Among non-Hispanic white family heads born in the 1980s, the college wealth premium is at a historic low; among all other races and ethnicities, it is statistically indistinguishable from zero [emphasis added]. Using variables available for the first time in the 2016 Survey of Consumer Finances, we find that controlling for the education of one’s parents reduces our estimates of college and postgraduate income and wealth premiums by 8 to 18 percent. Controlling also for measures of a respondent’s financial acumen—which may be partly innate—, our estimates of the value added bycollege and a postgraduate degree fall by 30 to 60 percent. Taken together, our results suggest that college and post-graduate education may be failing some recent graduates as a financial investment. We explore a variety of explanations and conclude that falling college wealth premiums may be due to the luck of when you were born, financial liberalization and the rising cost of higher education.
That paper is by William R. Emmons, Ana H. Kent and Lowell R. Ricketts, and comes from the St. Louis Fed, not from some bunch of (college-educated) cranks.
Via the excellent Samir Varma.
Libya, Yemen, Equatorial Guinea, Greece, the Central African Republic, Sudan, East Timor, Lebanon, Greece, and Trinidad & Tobago. In Syria and Venezuela data collection has stopped altogether, but they would make the list too.
Ethiopia had the highest growth rate of the decade, with Nauru, Rwanda, Ghana, Mongolia, Turkmenistan, Laos, China, India, Bangladesh, Cambodia, and Myanmar as other winners too. Note that the numbers for Turkmenistan are disputed, especially for the last few years of the decade, but still the country had a strong performance early on.
Here is the full FT piece by Steve Johnson.
Here are some projects I’d like to see funded, some through my own ventures, or others through alternative mechanisms. On these issues, the right person could have an enormous impact, whether through the research side or directly coming up with actionable ideas, including of course creating and building companies.
More studies of super-effective people. Either individually or collectively. If you take the outliers in any domain, what should our intuitions be for understanding the underlying processes determining how many people could have ended up in those positions? How many people had the right genes but had the wrong upbringing? How many people had the right genes and the right upbringing but the wrong luck, or perhaps society failed them in some other manner? The answers to these questions have significant policy implications.
A comprehensive analysis and critique of the NIH and NSF. The US funds more science research than any other country — about $35 billion per year on the NIH and $8 billion per year on the NSF. How exactly do these institutions work? How have they changed over time and have these changes been for good or bad? Based on what we now know, how might we better structure the NIH and NSF? What experiments should we run or what kind of studies should we perform?
Why is life expectancy so long in Hong Kong? Life expectancy in Hong Kong is 84.23 years, more than five years longer than the US and the highest in the world. Hong Kong is not that wealthy (median household income is $38,000 USD); it’s somewhat polluted; people don’t obviously eat what seems like a healthy diet; and they don’t seem to exercise a great deal. What should we learn from this?
Bloomberg Terminal for everything. This might be a nonprofit, a company, or a government project. To state the obvious, many analyses hinge on having the right data. If you’re in finance, getting the right data is often easy: just pull it up on your Bloomberg terminal. But there is no practical way to ask “what most correlates with life expectancy in Hong Kong?” (See above on that topic.) Figure out a way to build a growing corpus of structured data across the broadest variety of domains.
A comprehensive guide to the American healthcare system. The American healthcare system is by far the world’s biggest and also by a considerable margin the world’s most influential. Yet there is no comprehensive, dispassionate, and analytical disaggregation of how it all works. Who are the actors and what are their incentives? To the degree that the relationships between different entities are in equilibrium, what are the forces ensuring they stay there? What is the Sankey diagram of fund flows within the U.S. healthcare system?
Better answers for how to quantify worker productivity. In most knowledge industries, companies have nothing better than highly subjective measures (i.e., supervisors’ assessments) of worker productivity. In theory, it seems significant improvements should be possible. In the short term, is it possible to measure the productivity or efficacy of individual managers, software engineers, educators, scientists? How about teams, and what size of team? And can we do so without creating Goodhart’s Law problems?
What should Widodo do? Indonesia is a large, populous middle-income country. It faces no major near-term security threats. It has a small manufacturing base and no major non-commodity export sectors. What is the best non-bureaucratic 10 page economic development briefing document and set of prescriptions that one could write for Indonesia’s president? For Indonesia, substitute Philippines, Chile, or Morocco.
A comparative study of foundations and their efficacy. Philanthropic foundations are behind a lot of important work. But how does a foundation decide what it wants and how the resulting grants should be structured? How effective are the programs of that foundation? In practice, how have its institutional mechanisms evolved? Imagine some kind of resource that answered these questions for the major American foundations.
Institutional critiques. More broadly, there is no discipline of institutional criticism. There is a very rich literature of policy criticism in economics, journalism, and non-fiction books. There is also a rich literature of “corporate criticism”: there are thousands of articles about how Facebook (budget: $20 billion) works and how it might be good or bad. But there is relatively little analysis of the most important institutions in our society: government departments. How is the Department of Agriculture (budget: $150 billion) organized and how effective or not is it? How about the Department of Energy (budget: $32 billion)? And why are not those questions paramount in the minds of policymakers?
Cultures of excellence. If you ask informed Filipinos why the street food is mediocre, they will tell you that Philippines lacks a “culture of excellence”. It seems that some kind of “culture of doing things really well” has very persistent and generalizable effects. South Korea and Japan have developed much more rapidly than many Asian countries, despite many others adopting relatively free “Washington Consensus”-style trade policies. Russia still has higher GDP per capita than Mexico despite Mexico’s economic policies having been much better than Russia’s for many, many decades at this point. How should we think about cultures of excellence?
Regeneration at the government layer. Herbert Kaufman (unsurprisingly) concludes in an empirical study that government organizations don’t die. While we might all agree that this is a problem, actionable solutions are in short supply. What can or should we do about this?
IQ paradox. Ron Unz points out that intergenerational variation of IQ may be much higher than is often assumed, citing Ireland and Croatia as examples. For instance, not long ago Ireland had sub-par measured IQ and now that figure is much higher, following growth and prosperity. The policy implications of IQ disparities across nations may therefore be different to what might otherwise obviously follow: perhaps environment matters much more than is assumed. If so, what should we be doing more or less of?
Credible plans for new top-tier universities. 7 of the best 25 universities in the world (Times ranking) were started in the US between 1861 and 1891 by ambitious reformers. It’s probably harder in many ways to start an impactful new university today… but it’s likely not impossible and the returns to doing so successfully might be very high. What might be a good plan? Why have so few of these plans come to fruition?
Summaries of the state of knowledge in different fields. As a general matter, a lot of oral knowledge in the world is still not readily available, and reflection on this fact might lead one in many interesting directions. One obvious application is helping people more readily understand the present state of affairs in different domains. If I want to know “how we’re doing” in, say, antiviral drug development, I could spend a few hours hunting for top researchers, email a few, and perhaps get on calls to obtain their candid assessments. Are we making good progress? What are the most important open problems? What’s holding things back? And so on. How can we make all of this knowledge publicly available across all fields?
Mechanisms for better matching. One of the single interventions that could do the most to improve global welfare would be to improve the efficiency of the partner/marriage matching ecosystem. Online dating demonstrates that significant change (and maybe even improvement?) is possible, with some figures suggesting that up to two thirds of relationships in the US may now be initiated through online dating services. Accomplished people often seem to struggle with this challenge. Good solutions would be important.
What should Durkan do? Jenny Durkan is the current mayor of Seattle. As cities become more important loci of economic activity in the world, the importance of effective city governance will increase. As with the Widodo challenge, what is the best 10 page briefing document and set of prescriptions that one could write for her? What about Baltimore and St. Louis?
From my latest Bloomberg column:
The key point is the difference between income and wealth. GDP and related numbers measure income flows: namely, the quantity of goods and services produced in a given nation in a given year. Wealth is a measure of the total stock of resources in a nation and is much higher. Furthermore, the gap between wealth and income is usually higher for nations that have been wealthy and stable for a very long time, such as the U.S.
When it comes to national wealth, the U.S. has a big lead over China, possibly as much as three times greater. That is a very rough estimate by Michael Beckley of Tufts University, drawing on data from the World Bank and the United Nations.
For a relevant pointer to Beckley, I thank Evan Abramsky of AEI.
S&P Global: Four Republican lawmakers have authored new legislation to permit drugs for critically ill patients to enter the market before completing late-stage trials, saying the bill was necessary because the U.S. Food and Drug Administration’s regulatory process was too slow and burdensome.
The bill would create a time-limited conditional approval pathway in the U.S. similar to a system that has long been used by European regulators.
…The conditional approval would be valid for one year and could be renewed annually for up to five years….Companies would be required to meet certain obligations, like completing clinical investigations to provide full demonstration of safety and effectiveness and other studies.
…Companies could seek full U.S. approval at any time. The FDA would be required to let manufacturers include in their applications the real-world evidence they collected during the conditional approval period.
The lawmakers want the FDA to be able to grant the limited marketing authorization to new drugs that have successfully completed phase 1 and 2 trials, with the idea that companies could generate revenue to help fund their phase 3 studies.
They emphasized their legislation is targeted especially at small biopharmaceutical companies that may struggle to cover the costs of late-stage trials.
Under the dual-track approval system, companies would be able to sell pharmaceuticals earlier but would be required to track outcomes so greater real world information would be developed in the FDA process. The result is a more dynamic approval process better suited to modern medicine. The idea is due to the excellent Bartley J. Madden (note my bias).
Madden and Nobel-prize winner Vernon Smith explained the dual-track idea, noting:
Today’s world of accelerating medical advancements is ushering in an age of personalized medicine in which patients’ unique genetic makeup and biomarkers will increasingly lead to customized therapies in which samples are inherently small. This calls for a fast-learning, adaptable FTCM environment for generating new data. In sharp contrast, the status quo FDA environment provides a yes/no approval decision based on statistical tests for an average patient, i.e., a one-size-fits-all drug approval process.
A similar process has been adopted in Japan for regenerative medicine.
Pronomos Capital, which [Patri] Friedman incorporated in August, is supposed to bankroll the construction of experimental cities on vacant tracts of land in developing countries. Pronomos is set up like a venture fund, making investments in local organizations that do the work of securing government approvals, finding tenants, and hiring retired U.K. judges to enforce the new legal framework, to be based on British common law. The firm says it’s discussing semi-autonomous cities of varying sizes with foreign and local businesspeople in countries where officials have seemed receptive to exempting them from area laws, including Ghana, Honduras, the Marshall Islands, Nigeria, and Panama. A given community could start as small as an industrial park, Friedman says. Most will be aimed at foreign businesses seeking friendlier tax treatment…
The venture firm has raised about $9 million so far (more than half from Thiel), well short of Friedman’s initial goal. He says that’s only enough to cover basic fact-finding expenses for his local partners, and he’ll raise more to buy and develop land once governments approve the plans.
Here is more from Lizette Chapman at Bloomberg, interesting throughout.